CN103750922A - Artificial heart valve and valve leaflet manufacturing method - Google Patents
Artificial heart valve and valve leaflet manufacturing method Download PDFInfo
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- CN103750922A CN103750922A CN201310752640.3A CN201310752640A CN103750922A CN 103750922 A CN103750922 A CN 103750922A CN 201310752640 A CN201310752640 A CN 201310752640A CN 103750922 A CN103750922 A CN 103750922A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/367—Muscle tissue, e.g. sphincter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
- A61F2240/004—Using a positive or negative model, e.g. moulds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Vascular Medicine (AREA)
- Botany (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Manufacturing & Machinery (AREA)
- Heart & Thoracic Surgery (AREA)
- General Chemical & Material Sciences (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates to an artificial heart valve and valve leaflet manufacturing method. The method includes freezing animal tissue membranes and processing the animal tissue membranes in the frozen state to a set thickness. According to the artificial heart valve and valve leaflet manufacturing method, by processing the frozen animal tissue membrane, artificial heart valves and valve leaflets with a required thickness can be obtained conveniently, and the yield rate of animal tissue membrane valve leaflets can be improved.
Description
Technical field
The present invention relates to a kind of method of preparing Cardiac valve prosthesis lobe leaf, belong to technical field of medical instruments.
Background technology
Valvular heart disease is one of cardiopathic main species at present, can cause the great dysfunction of heart, and finally need to be with the autologous cardiac valve of artificial cardiac valve replacement.Biovalve is a class conventional Cardiac valve prosthesis at present.The lobe leaf of biovalve adopts animal tissue's film to make conventionally, and for example the pericardium of pig tremulous pulse valve or cattle is sewn on the lobe frame of Cardiac valve prosthesis after crosslinked and calcification are processed.
For meeting the function of valve, the lobe leaf of each valve need to meet specific indexes, for example in some cases, and the thickness that the different lobe leaves of same valve need to be consistent.For the biovalve of Srgery grafting, according to the difference of valve size, its requirement to lobe leaf thickness is generally 0.3-0.6mm.And the bovine pericardium thickness gathering from slaughterhouse is at present generally 0.1-0.8mm, and the thickness of every bovine pericardium each point is also inconsistent.Therefore every pericardium is often merely able to produce the lobe leaf that 1-2 sheet is qualified, and output yield rate is very low.And the biovalve of getting involved for percutaneous, for improve transvascular can transporting, need to reduce the prepackage diameter of getting involved valve, this makes to require animal tissue's film of employing thinner, often will be lower than 0.25mm, therefore can be used for animal tissue's film of the biovalve that percutaneous gets involved seldom, output yield rate is lower.
In other situations, in order to meet specific function, the lobe leaf each point of Cardiac valve prosthesis need to have different thickness, and above-mentioned processing method is difficult to meet.
Therefore, need to process animal tissue's film, to meet the requirement to valve lobe leaf thickness.In patent US7141064, disclose and adopted the method for pressurizeing in cross-linking process to obtain the more even or thinner animal tissue's film of thickness, can improve yield rate.Yet the method easily makes the corrugated fibers in animal tissue's film (as the pericardium of cattle) straighten, and reduces its elasticity, and then affect the effect that the bending of lobe leaf when cardiac dilatation and contraction unfolded, and be difficult to obtain the lobe leaf that each point variable thickness causes.Employing laser ablation is disclosed in patent US2013110097, US20130116676 and US20130310929, scraping, the methods such as grinding are processed and are made its even thickness or reduce the tissue of crosslinked or half cross-linked state, and can obtain the different lobe impeller structure of each dot thickness.But animal tissue's film that Cardiac valve prosthesis adopts mostly is soft tissue, adopts said method to add easily distortion or wrinkling, not easy to operate in man-hour, and after processing, be difficult to remove the residual chip of tissue.
Summary of the invention
The invention provides a kind of preparation method of Cardiac valve prosthesis lobe leaf, by freezing animal tissue film, process again, can obtain easily the Cardiac valve prosthesis lobe leaf of desired thickness, improve the output capacity of animal tissue's film lobe leaf, and can retain the original elastic fibrous layer of animal tissue's film.
The invention provides a kind of method of preparing Cardiac valve prosthesis lobe leaf, it comprises, animal tissue's film is freezing, and the animal tissue's film under freezing state is processed so that it reaches setting thickness.It will be understood by those skilled in the art that described animal tissue film is freezing under the state that launches or tile, be more conducive to the carrying out of described processing.
Further, use liquid nitrogen that described animal tissue film is freezing.
Further, described animal tissue film is immersed in and in liquid nitrogen, carries out described processing.
Further, described in, be processed as one or more in grinding, cutting, scraping, milling and grinding.
Further, before described animal tissue film is freezing, or the animal tissue's film under described freezing state is processed so that after it reaches and set thickness, also comprise described animal tissue film is made to Cardiac valve prosthesis lobe leaf required form.
Further, described animal tissue film is placed in Cardiac valve prosthesis lobe leaf thickness and is distributed on corresponding mould, more described animal tissue film is freezing.
Further, before described animal tissue film is freezing, also comprise and use cryoprotective agent to carry out pretreatment to it.
Further, described animal tissue's film under freezing state is processed so that it reaches and set thickness for the thickness integral body of described animal tissue film is reduced to a setting thickness, or the different parts of described animal tissue film is processed into different-thickness as required.
Further, described in, be processed as described animal tissue film is placed in the die that the degree of depth is described setting thickness and processes that the integral thickness of described animal tissue film is reduced to described setting thickness.
Further, described animal tissue film is mammiferous pericardium, diaphragm or cerebral dura mater.
Further, described processing is that the matsurface of described animal tissue film is carried out.
Further, described animal tissue film is the animal tissue's film after crosslinking Treatment.
The present invention program's enforcement, at least has following advantage:
1, method provided by the invention, when obtaining the Cardiac valve prosthesis lobe leaf of desired thickness, is easily fixed and processing animal tissue's film, and can reduce the damage of animal tissue's film, has increased the thickness and precision of Cardiac valve prosthesis lobe leaf;
2, method provided by the invention can improve the output capacity of Cardiac valve prosthesis lobe leaf, and then reduces raw-material use cost;
3, method provided by the invention can retain the fibrolaminar spring function of corrugated in animal tissue's film (as mammiferous pericardium), and effect is unfolded in the bending when guaranteeing artificial heart valve leaflet at cardiac dilatation and shrinking.
Accompanying drawing explanation
Fig. 1 is the artificial valvular structural representation of a kind of intervention.
Fig. 2 is the lobe leaf that can be used for getting involved in Fig. 1 Cardiac valve prosthesis prepared by one embodiment of the invention.
Fig. 3 A and Fig. 3 B are lobe leaf prepared by another embodiment of the present invention.
Fig. 4 is the flow chart of Cardiac valve prosthesis lobe leaf preparation method provided by the invention.
The schematic diagram of the Cardiac valve prosthesis lobe leaf preparation method that Fig. 5 provides for one embodiment of the invention.
The schematic diagram of the Cardiac valve prosthesis lobe leaf preparation method that Fig. 6 provides for another embodiment of the present invention.
The specific embodiment
Accompanying drawing referring to the embodiment of the present invention is described the present invention more fully.Yet the present invention can many multi-form embodiments, should not be construed as and be limited to the embodiment of statement herein.
The invention provides a kind of preparation method of Cardiac valve prosthesis lobe leaf, by freezing animal tissue film, process again, can obtain easily the Cardiac valve prosthesis lobe leaf of desired thickness, improve the output capacity of animal tissue's film lobe leaf, and can retain the original elasticity of animal tissue's film.
Pretreatment before freezing:
Because of in the animal tissue's film adopting containing certain water, conventionally need Dui Gai animal tissue film to carry out pretreatment before freezing, the structural intergrity of the tissue film that is more conducive to watch for animals.Pretreatment before freezing can directly be carried out full wafer animal tissue, also can carry out being tailored into the animal tissue of the leaf shape of lobe.Pretreatment before freezing Wei Jianggai animal tissue film immerses in cryoprotective agent to be processed.Described cryoprotective agent can be the materials such as glycerol, dimethyl sulfoxide, ethylene glycol or propylene glycol.
Freezing:
After carrying out pretreatment before freezing, by animal tissue's film be placed in refrigerating plant (as containers such as liquid nitrogen containers) carry out freezing, until this animal tissue's film is to add man-hour indeformable, thus till can processing.In order to be more conducive to the carrying out of described processing, described animal tissue film is freezing under the state that launches or tile.Also animal tissue's film can be placed in lobe leaf thickness and distribute on corresponding mould in freezing front tiling; As adopt central protuberance, the mould of the relative lobe depression of surrounding, can make animal tissue's film fit with mould in refrigerating process, during following process, can directly animal tissue's film be processed into plane with the one side of mould laminating, and the position thickness of fitting in the intermediate projections position that makes described animal tissue film and mould is less, the position thickness of the depression position laminating of surrounding and mould is larger, can prepare and have the lobe leaf that respective thickness distributes.
In the present invention, can use the liquid nitrogen being purchased, temperature generally ,-196 ℃ of left and right, can realize quick freezing.
Processing:
After animal tissue's film is freezing, on a surface of freezing state Xia Dui animal tissue film, process.Can on Xian animal tissue film, determine the region that need to make lobe leaf, when the actual required thickness (setting thickness) in each position of lobe leaf is consistent, the above-mentioned thickness that reduces this thicker position of region animal tissue film that is processed as makes its even thickness in this region consistent; Or, for some, setting the less lobe leaf of thickness, can process again, the thickness that further integral body reduces animal tissue's film makes it meet setting thickness.When the setting variable thickness at each position of lobe leaf causes, can directly by the desired setting thickness in each position, process.Or, the thickness of animal tissue's film integral body is machined to and is a bit larger tham the desired setting thickness in each position of lobe leaf, and then determine the region that need to make lobe leaf on animal tissue's film, and as required the animal tissue's film in this region is carried out to thickness processing.
After Dui Gai animal tissue film machines, can under freezing state, by modes such as machine cuts, be processed into lobe leaf required form, also can after thawing, by modes such as machinery or laser, be processed into the required shape of lobe leaf.
Or first Jiang Gai animal tissue film is made the shape described in lobe leaf in the usual way before freezing, then carry out freezingly, under freezing state, to process as required afterwards, the thickness that reduces this thicker position of region animal tissue film makes its even thickness; Or, for some, setting the less lobe leaf of thickness, can process again, the thickness that further integral body reduces animal tissue's film makes it meet less setting thickness, also can directly by the desired setting thickness in each position, process.
Wherein the above-mentioned processing under freezing state can be selected from grinding, cutting, scraping, milling, grinding etc. other arbitrarily can a part or whole part reduces the method for tissue thickness, also said method can be used in combination.Such as animal tissue's film is fixed on, in frock clamp, puts into together liquid nitrogen and carry out freezingly, then will process with the animal tissue's film after frock clamp freezing; Can certainly fix by first freezing row again, then process.Described processing can be processed for being fixed on grinding (as grinding machine), milling (as milling machine) or cutting (as planer) equipment, or adopts manual grinding tool, milling tool or scraper etc. to process it.
In the present invention, the animal tissue's film using is any animal tissue film that can be used for Cardiac valve prosthesis lobe leaf, as pericardium of mammal cattle, horse (or satisfactory bag sheet) etc.Described animal tissue film has a rough surface smooth surface relative to conventionally, other organizes the surface being connected to rough surface often with in organism, and with the smooth surface part inner coated tissue of this animal tissue film often that is close, be generally the corrugated elastic fibrous layer being formed by collagen protein etc.In concrete embodiment, can select the matsurface of animal tissue's film to process, after processing, be beneficial to reservation elastic fibrous layer like this, and make matsurface become smooth.
In some cases, lobe leaf different parts can have different-thickness, is convenient to be connected and fixed with lobe leaf fixture, improves the durability of lobe leaf, or lobe leaf is supported and prevents that it from caving in.In the present invention, can to animal tissue's film, process according to the demand.Such as lobe leaf and lobe frame need to be sewed up the position being connected and can retain larger thickness; Or thickness structure and the mechanics feature of simulation Human Physiology valve, be processed into the thickness structure with Human Physiology valve with same or similar thickness distribution.
In the present invention, describedly under freezing state, process, the tissue of required processing or lobe leaf can directly be immersed in liquid nitrogen, and can be fixed by frock clamp; Or the tissue after freezing or lobe leaf are placed in the device that adopts liquid nitrogen refrigerating or are placed in the apparatus surface that adopts liquid nitrogen refrigerating, be conducive to maintain its freezing state, be easy to process operation simultaneously.
In the present invention, when the setting consistency of thickness of needs, adding man-hour Ke Jiang animal tissue film is placed in die, described negative mold has the groove of desired thickness and shape, the degree of depth of groove is and required setting consistency of thickness that the machining tool (as hand scaler or milling tool) that adopts working surface to be a bit larger tham die width is processed, and utilizes die surface to carry out spacing, can make like this machining tool move along die outer surface, obtain animal tissue's film of consistency of thickness.Use die to process and be easier to operation, and be conducive to obtain more animal tissue's film of uniformity of thickness.
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described.
The present embodiment provides a kind of preparation method of Cardiac valve prosthesis lobe leaf.Fig. 1 is a kind of structural representation of manpower intervention valve.This valve comprises cylindrical frame 100, has the lobe impeller structure 200 of 3 lobe leaves and sew up skirt 300.Lobe impeller structure 200 is arranged on the inside of cylindrical frame 100, and wherein each lobe leaf has shape as shown in Figure 2, and is fixed on cylindrical frame 100 by stitching thread.Sew up skirt 300 along being circumferentially arranged between cylindrical frame 100 and lobe impeller structure 200.
Wherein, the preparation flow of lobe leaf 20 as shown in Figure 4, using its thickness of pericardium sheet 1(of the cattle of using as lobe leaf gathering between 0.3-0.8mm) carrying out the pretreatment before freezing, then put it in hand basket 2, above-mentioned pericardium sheet 1 can be through crosslinked pericardium sheet, is conducive to improve the stability of the tissue of pericardium sheet.Then hand basket 2 is put into liquid nitrogen container 3 freezing.From 2 taking out the surface 31 that is fixed on liquid nitrogen refrigerating equipment in liquid nitrogen container 3 and hand basket, because this surface is as the datum plane that adds thickness measure in man-hour, therefore require it smooth pericardium sheet 1 after freezing, in the time of fixedly, make pericardium sheet 1 shiny surface downward.
Adopt as shown in Figure 5 the mode of grinding to polish to fixing pericardium sheet 1 rough surface, directly cause pericardium sheet 1 thickness is polished to 0.25mm, so that its even thickness is consistent.Then take off the pericardium sheet 1 after polishing, clean, remove chip and residue after polishing.Then thaw, then become the required leaf shape of lobe according to the suitable region processing of the selection of dimension of lobe leaf, finally obtain lobe leaf 20.
Embodiment 2
The present embodiment provides a kind of preparation method of Cardiac valve prosthesis lobe leaf, and it can be used for the intervention valve of describing in 1 as implemented, and also can be applied to other and adopt animal pericardium sheet film to make the biovalve of lobe leaf.
Wherein, lobe leaf 20 preparation methoies still can as shown in Figure 4, be cut out the pericardium sheet of cattle into the leaf shape of lobe; Select the pericardium sheet 1 with the leaf shape of lobe that each position thickness is all greater than the setting thickness of final demand, it is carried out to freezing front pretreatment; The pericardium sheet 1 then this to the leaf shape of lobe is put into the die shown in Fig. 6, makes pericardium sheet 1 shiny surface downward while putting into; Groove shapes in described die is identical with lobe leaf profile, and the degree of depth of groove is the setting thickness of lobe leaf; Then this pericardium sheet 1 is together put into hand basket 2 together with die, hand basket 2 is put into liquid nitrogen container 3 freezing.Die after freezing is taken out together with this pericardium sheet 1, die is fixed on to the surface 31 of liquid nitrogen refrigerating equipment.
As shown in Figure 6, adopt the mode of scraping to process, the size of the scraper working surface of use is greater than the width of groove, and the pericardium sheet 1 that successively this is had to the leaf shape of lobe carries out scraping, until the thickness of this pericardium sheet 1 equals depth of groove (being the setting thickness of lobe leaf), obtain lobe leaf.Because scraper size is larger, die edge can play position-limiting action like this, is conducive to control the thickness and precision of final lobe leaf, improves the uniformity of its thickness.After machining, the lobe leaf of acquisition is taken off, clean, remove chip and residue after polishing, then thaw.
The present embodiment provides a kind of manufacture method of different-thickness lobe leaf.The lobe impeller structure of different-thickness can be with reference to the lobe leaf in patent US20130116676, as shown in Figure 3A, its relative centre of lobe leaf periphery is thicker, so that increase the intensity while sewing up with lobe frame, its centre can also arrange reinforcement in addition, when lobe leaf is thinner, lobe leaf is played a supportive role.Also can have similar thickness with Human Physiology valve as shown in Figure 3 B and distribute, the centre of lobe leaf is thinner, the relative centre of periphery progressive additive.
Wherein, the preparation method of lobe leaf 20 still can as shown in Figure 4, be cut out the pericardium sheet 1 of cattle into the leaf shape of lobe; Select the pericardium sheet 1 with the leaf shape of lobe that each position thickness is all greater than the setting thickness of final demand, it is carried out to freezing front pretreatment; The pericardium sheet 1 then this to the leaf shape of lobe is put into the die shown in Fig. 6, makes pericardium sheet 1 shiny surface downward while putting into; Groove shapes in described die is identical with lobe leaf profile, and the degree of depth of groove can be the setting thickness of lobe leaf thinnest part; Then this pericardium sheet 1 is together put into hand basket 2 together with die, hand basket 2 is put into liquid nitrogen container 3 freezing.Die after freezing is taken out together with this pericardium sheet 1, die is fixed on to the surface 31 of liquid nitrogen refrigerating equipment.
Adopt as shown in Figure 6 scraping mode to process, or adopt as shown in Figure 5 the mode of grinding to process.When scraping or grinding, can adopt less cutter head or bistrique, be beneficial to part and reduce thickness, Dui Ge position, processing limit, limit is measured, until each position is all worked into required setting thickness, obtains lobe leaf 20.After machining, take off lobe leaf 20, clean, remove chip and residue after scraping or polishing, then thaw.
Finally it should be noted that: each embodiment, only in order to technical scheme of the present invention to be described, is not intended to limit above; Although the present invention is had been described in detail with reference to aforementioned each embodiment, those of ordinary skill in the art is to be understood that: its technical scheme that still can record aforementioned each embodiment is modified, or some or all of technical characterictic is wherein equal to replacement; And these modifications or replacement do not make the essence of appropriate technical solution depart from the scope of various embodiments of the present invention technical scheme.
Claims (12)
1. a method of preparing Cardiac valve prosthesis lobe leaf, it comprises, animal tissue's film is freezing, and the described animal tissue film under freezing state is processed so that it reaches setting thickness.
2. method according to claim 1, wherein, is used liquid nitrogen that described animal tissue film is freezing.
3. method according to claim 2, wherein, is immersed in described animal tissue film in liquid nitrogen, to carry out described processing.
4. method according to claim 1, wherein, described in be processed as one or more in grinding, cutting, scraping, milling and grinding.
5. method according to claim 1, wherein, before described animal tissue film is freezing, or the animal tissue's film under described freezing state is processed so that after it reaches and set thickness, also comprise described animal tissue film is made to Cardiac valve prosthesis lobe leaf required form.
6. method according to claim 1, wherein, is placed in described animal tissue film with Cardiac valve prosthesis lobe leaf thickness and distributes on corresponding mould, more described animal tissue film is freezing.
7. method according to claim 1, wherein, before described animal tissue film is freezing, also comprise and uses cryoprotective agent to carry out pretreatment to it.
8. method according to claim 1, wherein, described animal tissue's film under freezing state is processed so that it reaches and set thickness for the thickness integral body of described animal tissue film is reduced to a setting thickness, or the different parts of described animal tissue film is processed into different-thickness as required.
9. method according to claim 8, wherein, described in be processed as described animal tissue film be placed in the die that the degree of depth is described setting thickness and process that the integral thickness of described animal tissue film is reduced to described setting thickness.
10. method according to claim 1, wherein, described animal tissue film is mammiferous pericardium, diaphragm or cerebral dura mater.
11. according to the method described in claim 1 or 10, and wherein, described processing is that the matsurface of described animal tissue film is carried out.
12. methods according to claim 1, wherein, described animal tissue film is the animal tissue's film after crosslinking Treatment.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310752640.3A CN103750922B (en) | 2013-12-31 | 2013-12-31 | The method preparing Cardiac valve prosthesis leaflet |
| EP14877472.2A EP3090704B1 (en) | 2013-12-31 | 2014-03-24 | Method for preparing artificial heart valve leaflets |
| PCT/CN2014/073977 WO2015100858A1 (en) | 2013-12-31 | 2014-03-24 | Method for preparing artificial heart valve leaflets |
| JP2016544096A JP6386564B2 (en) | 2013-12-31 | 2014-03-24 | Method for producing leaflets of artificial heart valve membrane |
| US15/197,676 US10149755B2 (en) | 2013-12-31 | 2016-06-29 | Method for preparing an artificial heart valve leaflet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310752640.3A CN103750922B (en) | 2013-12-31 | 2013-12-31 | The method preparing Cardiac valve prosthesis leaflet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103750922A true CN103750922A (en) | 2014-04-30 |
| CN103750922B CN103750922B (en) | 2016-07-13 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310752640.3A Active CN103750922B (en) | 2013-12-31 | 2013-12-31 | The method preparing Cardiac valve prosthesis leaflet |
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| US (1) | US10149755B2 (en) |
| EP (1) | EP3090704B1 (en) |
| JP (1) | JP6386564B2 (en) |
| CN (1) | CN103750922B (en) |
| WO (1) | WO2015100858A1 (en) |
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| CN115350331A (en) * | 2022-08-26 | 2022-11-18 | 中国医学科学院生物医学工程研究所 | Artificial heart valve leaflet and preparation method thereof |
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| AU2020295566B2 (en) | 2019-06-20 | 2023-07-20 | Neovasc Tiara Inc. | Low profile prosthetic mitral valve |
| CN112402059B (en) * | 2020-10-16 | 2022-04-05 | 金仕生物科技（常熟）有限公司 | Sewing method of valve and valve leaflet and intervention valve |
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Also Published As
| Publication number | Publication date |
|---|---|
| US20160310266A1 (en) | 2016-10-27 |
| JP2017500976A (en) | 2017-01-12 |
| EP3090704A1 (en) | 2016-11-09 |
| WO2015100858A1 (en) | 2015-07-09 |
| EP3090704A4 (en) | 2017-10-18 |
| EP3090704B1 (en) | 2019-04-24 |
| JP6386564B2 (en) | 2018-09-05 |
| CN103750922B (en) | 2016-07-13 |
| US10149755B2 (en) | 2018-12-11 |
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